(14 days)
The Digital Clinical thermometers, Models ACT 3020's intended use are medical devices, supplied by internal power and intended to precisely measure human boduy temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.
Digital Clinical Thermometers, Models ACT 3020
The provided text is a 510(k) premarket notification letter from the FDA for a Digital Clinical Thermometer, Model ACT 3020. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, study designs, or performance metrics in the way that would typically be found in a clinical study report for AI/machine learning devices.
Therefore, many of the requested sections regarding AI/ML device performance and study specifics cannot be answered from this document.
Here's an attempt to extract relevant information and note what is not available in the provided text:
1. Table of acceptance criteria and the reported device performance
This information is not provided in the document. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance meets established standards, but it does not specify those standards or directly report the device's measured performance against them.
2. Sample size used for the test set and the data provenance
This information is not provided. This document is a regulatory approval letter, not a study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided.
4. Adjudication method for the test set
This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided. The device is a "Digital Clinical Thermometer," which is a measurement device and not typically an AI/machine learning diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. Again, given the device type, this concept may not be applicable. The "standalone" performance here would refer to the thermometer's accuracy in measuring temperature.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a clinical thermometer, the "ground truth" would typically be a reference standard for temperature measurement. This information is not explicitly stated in the document, but it would have been part of the underlying testing to demonstrate accuracy and substantial equivalence.
8. The sample size for the training set
This information is not provided. This device is not an AI/machine learning product that would have a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not provided. As above, this concept is not applicable to this type of device.
Summary of what is available from the document:
- Device Name: Digital Clinical Thermometer, Model ACT 3020
- Manufacturer: Actherm, Incorporated
- Regulation Number: 880.2910
- Regulation Name: Clinical Electronic Thermometer
- Regulatory Class: II
- Product Code: FLL
- K Number: K021614
- Indications for Use: To precisely measure human body temperature. It can be used for oral, axillary, and rectal temperature measurement.
- Basis of Approval: Substantial equivalence to legally marketed predicate devices (specifically mentions K010238 for Actherm Digital Clinical Thermometers).
The document is a regulatory communication confirming that the device is substantially equivalent to existing devices and can be marketed. It does not delve into the specific technical details or study results that would demonstrate performance against detailed acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2002
Mr. Richard Hsieh Marketing & Sales Manager Actherm, Incorporated 6th, No. 85 Kuan-Min 6 Road Jubei, HsinChu 302, TAIWAN
Re: K021614
Trade/Device Name: Digital Clinical Thermometer, Model ACT 3020 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 10, 2002 Received: May 16, 2002
Dear Mr. Hsieh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements
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Page 2 - Ms. Hsieh
of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known)
Device Name
Digital Clinical Thermometers, Models ACT 3020
Indications for Use
The Digital Clinical thermometers, Models ACT 3020's intended use are medical devices, supplied by internal power and intended to precisely measure human boduy temperature. It can be used in the measurement of oral, axillary and rectal temperature. I This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801. 109)
Over-The-Counter Use
Patricia Current
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
OR
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.